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Sponsors and Collaborators: |
Malaria Vaccine and Drug Development Center Fundacion Clinica Valle del Lili |
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Information provided by: | Malaria Vaccine and Drug Development Center |
ClinicalTrials.gov Identifier: | NCT00367380 |
The study is a randomized open label clinical trial to verify the reproducibility of a sporozoite challenge model for Plasmodium vivax in humans. The verification of the reproducibility of such a model will make it possible to evaluate the efficacy of candidate P. vivax vaccines in Phase 2a trials. The study is divided into two successive steps:
Step A Parasite Blood Donation: Volunteers will be recruited passively from a group of patients who present with active P. vivax infection and accept to donate infected blood. Samples of P. vivax infected blood will be collected and will be screened for infectious diseases, according to standard blood bank procedures. Colonized Anopheles albimanus mosquitoes will be fed with this blood using a Membrane Feeding Assay (MFA). Sixteen (16) days after, selected positive mosquito batches will be used for step B.
Step B Challenge: After informed consent signature, a total of 24 healthy volunteers will be randomly allocated to Groups 1, 2 and 3, of 8 volunteers each and will be challenged with the bite of 3±1, P. vivax infected mosquitoes. Each group will be exposed to a different isolated parasite. Volunteers will be closely monitored post infection, and will be treated as soon as blood infection becomes patent as ascertained by microscopic examination of thick blood smears (TBS). Comparison of data obtained in the three different groups will be used to determine reproducibility of challenge model.
Primary objective: To demonstrate that naïve human volunteers can be safely and reproducibly infected by the bite of An. albimanus mosquitoes carrying P. vivax sporozoites in their salivary glands.
Secondary objective: To determine the influence of the type of parasite isolated on reproducibility and safety of the challenge model with P. vivax in human volunteers
Hypothesis:It is possible to safely develop a reproducible P. vivax infection in human volunteers using P. vivax experimentally infected An. albimanus mosquitoes.
Condition | Intervention | Phase |
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Malaria Fever SWEATING Shaking Chills Anemia |
Drug: Chloroquine phosphate Drug: Primaquine Drug: Fansidar (sulfadoxine-pyrimethamine) Drug: Amodiaquine |
Phase II |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Evaluation of Reproducibility of a Sporozoite Challenge Model for Plasmodium Vivax in Human Volunteers |
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Colombia, Valle | |
Malaria Vaccine and Drug Development Center | |
Cali, Valle, Colombia, 25574 |
Principal Investigator: | Socrates Herrera, MD | Director |
Study ID Numbers: | MVDC-2006-004 |
Study First Received: | August 19, 2006 |
Last Updated: | June 15, 2007 |
ClinicalTrials.gov Identifier: | NCT00367380 |
Health Authority: | Colombia: Fundacion Clinica Valle del Lili; Colombia: Centro Medico Imbanaco |
Malaria Sporozoite Challenge Model Plasmodium vivax Human Volunteers |
Pyrimethamine Protozoan Infections Sulfadoxine-pyrimethamine Amodiaquine Primaquine Anemia Chloroquine |
Malaria Sulfadoxine Fever Folic Acid Chloroquine diphosphate Parasitic Diseases |
Anti-Inflammatory Agents Anti-Infective Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Renal Agents Antimalarials Antiparasitic Agents Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Amebicides |
Antinematodal Agents Coccidiosis Filaricides Anthelmintics Enzyme Inhibitors Anti-Infective Agents, Urinary Folic Acid Antagonists Pharmacologic Actions Analgesics, Non-Narcotic Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |